EN_TR_T2006 Tibia Interlocking Nail System Surgical Technique

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EN_TR_T2006 Tibia Interlocking Nail System Surgical Technique
T2006
T2006 TIBA KÝLÝTLÝ
ÇÝVÝ SÝSTEMÝ
T2006 TIBIA INTERLOCKING
NAIL SYSTEM
TIBIA INTERLOCKING
NAIL SYSTEM
The key in
orthopaedic
sciences
SURGICAL TECHNIQUE
CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS
ÝMPLANTLAR VE EL ALETLERÝ
T 2006
TIBIA INTERLOCKING NAIL SYSTEM
CONTENTS
Introduction
Giriþ
ÝÇÝNDEKÝLER
2
Accessing the Tibial Canal
4
Reaming
4
Nail Selection
6
Guide Fixed
6
Nail Insertion
7
Proximal Locking
7
Distal Locking
8
Tibial Kanala Eriþim
Oyma
Çivi Seçimi
Klavuzun Sabitlenmsi
Çivinin Yerleþtirilmesi
Proksimal Kilitleme
Distal Kilitleme
End Cap Insertion
10
Instruments&Trays
11
End Cap Yerleþtirilmesi
El Aletleri&Tavalar
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
T20 0 6
TIBIA INTERLOCKING NAIL SYSTEM
Introduction
Giriþ
This interlocking nail system is the result of long term experience in medullary nailing.
This nail can be used for open tibial shaft fractures and closed tibial shaft
fractures. This tibial nail offer unbeatable versality in the treatment specialy for traumatic,
pathologic, nonunion and reconstructive surgery and makes possible treating of fractures
within a range of 60% of the tibial length.
Bu kilitli çivi sisitemi medular çivilerdeki uzun süren tecrübe ve deneyimlerimizin bir
ürünü olarak karþýnýza çýkmýþtýr. Bu çivi açýk ve kapalý tibial þaft kýrýklarýnda kullanýlabilir. Tibial
çivi traumatic, patolojik, nonunion ve rekonstrüksiyon cerrahisinde çok yönlü bir þekilde
kullanýlabilir ve tibial uzunluðun %60’ýna kadar olan kýrýklarda tedavi imkaný sunar.
Material
Malzeme
Certified Stainless Steel according to ASTM F 138 and ISO 5832-1and Titanium alloy
according to ASTM F 136 and ISO 5832-3.
ASTM F 138 ve ISO 5832-1’ya göre sertifikalý paslanmaz çelik ve ASTM F 138 ve ISO
5832-3’e göre sertifikalý titanyum alaþým.
Length
Titanium alloy
Titanyum Alaþýmý
L
Paslanmaz Çelik
Stainless Steel
ØD
Uzunluk
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
Reference Number: 1080122 XXXX
Referans Numarasý: 1080122 XXXX
mm
Ø8
Ø9
Ø10
Ø11 Ø12
Ø13
270
285
300
315
330
345
360
380
400
420
440
1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1051
1052
1053
1054
1055
1056
1057
1058
1059
1060
1061
1101
1102
1103
1104
1105
1106
1107
1108
1109
1110
1111
1151
1152
1153
1154
1155
1156
1157
1158
1159
1160
1201
1202
1203
1204
1205
1206
1207
1208
1209
1210
1251
1252
1253
1254
1255
1256
1257
1258
1259
1260
270
285
300
315
330
345
360
380
400
420
440
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2051
2052
2053
2054
2055
2056
2057
2058
2059
2060
2061
2101
2102
2103
2104
2105
2106
2107
2108
2109
2110
2111
2151
2152
2153
2154
2155
2156
2157
2158
2159
2160
2201
2202
2203
2204
2205
2206
2207
2208
2209
2210
2251
2252
2253
2254
2255
2256
2257
2258
2259
2260
2
T 2006
TIBIA INTERLOCKING NAIL SYSTEM
Length
Canullated Locking Screws
Kilitleme Vidalarý
Kanüllü Kilitleme vidalarý
Uzunluk
Stainless Steel
Paslanmaz Çelik
Titanyum Alaþýmý
Titanium alloy
Stainless Steel
Paslanmaz Çelik
Titanyum Alaþýmý
25
30
35
40
45
50
55
60
65
70
75
80
85
90
10802281001
10802281002
10802281003
10802281004
10802281005
10802281006
10802281007
10802281008
10802281009
10802281010
10802281011
10802281012
10802281013
10802281014
10802282001
10802282002
10802282003
10802282004
10802282005
10802282006
10802282007
10802282008
10802282009
10802282010
10802282011
10802282012
10802282013
10802282014
10802301001
10802301002
10802301003
10802301004
10802301005
10802301006
10802301007
10802301008
10802301009
10802301010
10802302001
10802302002
10802302003
10802302004
10802302005
10802302006
10802302007
10802302008
10802302009
10802302010
mm
Ø5.0
Locking Screws
Length
Uzunluk
mm
32
36
40
44
48
52
Titanium alloy
Ø5.0
Large Cortical Screw
with self-tapping
Self-tapping Kortikal Vida
Stainless Steel
Titanium alloy
Paslanmaz Çelik
Titanyum Alaþýmý
10802371012
10802371014
10802371016
10802371018
10802371020
10802371022
10802372012
10802372014
10802372016
10802372018
10802372020
10802372022
Ø4.5
Locking End Cap
Kilitli Kuntscher Bolt Vidasý
Stainless Steel
Titanium alloy
Paslanmaz Çelik
Titanyum Alaþýmý
10802291002
10802292002
Please Note : This document is intended as a guide for the surgeon only. There are multiple
techniques for the insertion of T2006 Tibia Interlocking Nail System and, as with any surgical
procedure, a surgeon should be thoroughly trained and beware that this procedure is
appropriate for the patient before proceeding.
Not: Bu doküman cerrahlar için bir klavuz niteliðindedir. T2006 Tibia Kilitli Çivi Sistemi
uygulanmasý için çoklu teknikler mevcuttur ve diðer cerrahi iþlemlerde olduðu gibi cerrah
derinlemesine eðitimli olmalý ve iþlemin hastaya uygun olduðundan emin olmalýdýr.
3
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
T2 0 0 6
TIBIA INTERLOCKING NAIL SYSTEM
Accessing the Tbial Canal
Tibial Kanala Eriþim
A starting point is made either with a
guide pin or an
Cortical Awl
(Ref:10606111002) based on surgeon
preference. Use A/P and lateral fluoroscopic
views to confirm accurate placement. For
midshaft and distal tibia fractures, a central
starting point in the A/P view is adequate. For
more proximal fractures, however, a slightly
lateral starting point is recommended to avoid
proximal fragment malalignment.
Cerrahýn tercihine baðlý olarak
baþlangýç noktasý kýlavuz teli veya Kortikal Awl
(Ref:10606111002) yardýmýyla oluþturulabilir.
Kesin konumlandýrmayý A/P ve lateral
görüntülerle doðrulayýnýz. Orta þaft ve distal
tibia kýrýklarýnda A/P görüntüsündeki merkezi
giriþ noktasý yeterlidir. Daha fazla proksimal
kýrýklarda proksimal parçanýn yanlýþ
konumlandýrýlmasýndan kaçýnmak için kýsmi
bir lateral baþlangýç noktasý seçmeniz tavsiye
edilir.
Reaming
Oyma
Place an Flexible Reamer (Ref:1061009
. . . .) over the guide wire and ream the tibial
canal in 1 millimeter increments until contact
is made with the cortical wall. Continue to
ream in 1 millimeter increments up to 1
millimeter greater than the selected nail
diameter.
Klavuz Telinin üzerinden bir Flexible
Reamer (Ref:1061009 . . . .) yerleþtiriniz ve
kortikal duvarla karþýlaþana kadar 1 mm’lik
artýþlarla tibial kanalý oyunuz. Oyma iþlemine
delik seçilen çivinin çapýndan 1 mm büyük
olana kadar devam ediniz.
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
4
T 2 006
TIBIA INTERLOCKING NAIL SYSTEM
Nail Selection
Çivi Seçimi
Nail length is determined by measuring the remaining length of the guide wire.
The diameter of the selected nail should be 1mm smaller than that of the last reamer
used. Tibial Nails are available in 1 mm increments from 8 mm to 13 mm diameters.
Çivi uzunluðu, kalan kýlavuz telinin uzunluðuna göre tespit edilir. Seçilen çivinin çapý
son kullanýlan oyucunun çapýndan 1 mm daha küçük olmalýdýr. Tibial çiviler 8’den 13
mm’ye kadar 1 mm’lik aralýklarla bulunmaktadýr.
Guide Fixed
Klavuzun Sabitlenmesi
The selected nail is assembled on to
the Tibia Guide Attachment (Ref:10606460010)
fixed with Tibia guide Screw (Ref:10606460015).
The curvature of the nail must match the
curvature of the reamed tibia.
Seçilen çivi tibia guide vidasý
(Ref:10606460010) vasýtasýyla tibia guide
attachment’e (Ref:10606460015) baðlanýr.
Çivinin eðikliði ile oyularak hazýrlanmýþ olan
kanal eðikliði birbirine denk olmalýdýr.
The Tibia Guide-Long (Ref:10606460025)
is slided into the Tibia Guide Attachment and
fixed with the Guide Fixed Screw at the nail
length. The nail lengths are marked on the
Tibia Guide-Long for easier alignment (Fig.1).
Tibia Guide Long (Ref:10606460025)
tibia guide attachment üzerinde kaydýrýlarak
çivi uzunluðuna gelince guide sabitleme
vidalarýyla sabitlenir. Kolay bir hizalama
yapmak için çivi uzunluklarý tibia guide long
üzerinde iþaretlenmiþtir (Þekil 1).
Two fixation guides (Ref:10606460028) are slided into the adjustable sliding apparatus
(Fig.2) located at the end of Tibia Guide-Long so that the apparatus is aligned with the
distal holes in the tibia nail. With T-Wrench (Ref:10604071105) or (Ref:10604011402) the
alignment is fixed for further operative steps. Check if the fixation is done appropriate by
letting the Fixation Guides glide from the fixed adjustable sliding apparatus directly in the
distal holes of the nail. If these Fixation Guides are nothing the holes easily realignment is
needed.
Ýki adet fiksasyon guide (Ref:10606460028) ayarlanabilir kaydýrma aparatýndan
kaydýrýlarak tibia guide long üzerine yerleþtirilir (Þekil 2). Böylece aparat tibia çivisindeki
distal deliklerle hizalanmýþ olur. Bu hizalama T Anahtarý (Ref:10604071105) veya
(Ref:10604011402) ile diðer adýmlar için sabitlenir. Fiksasyonun uygunluðunu, fiksasyon
guide’larý sabitlenmiþ ayarlanabilir aparattan çivinin distal deliklerine doðru uzatarak,
kontrol ediniz. Eðer fiksasyon guide’leri deliklere kolayca geçmiyorsa yeniden ayarlama
ihtiyacý oluþabilir.
5
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
T200 6
TIBIA INTERLOCKING NAIL SYSTEM
Nail Insertion
Çivinin Yerleþtirilmesi
All additional apparatus used for guidance are detached from the Tibia Guide
Attachment except tibia nail. Tibia Guide-Long and the adjustable sliding apparatus are
aligned for distal holes of the tibial nail. This alignment and the nail length will be used in
further steps. Do not realign or change the nail length. Gently slide the tibial nail into the
hole opened previously by hand as far as possible. Slide Hammer (Ref:10611031001)
attached to the Tibia Guide Screw. Tibial Nail is impacted using the Slide hammer. Avoid
excessive force while inserting the nail.
Tibia çivisi dýþýndaki tüm aparatlar rehberlik etmesi için kullanýlýr ve tibia guide
attachment’den ayrý parçalardýr. tibia guide long ve ayarlanabilir kayan aparat femoral
çivinin distal deliklerine hizalanýr. Bu hizalama ve çivi uzunluðu ileriki aþamalarda iþimize
yarayacaktýr. Bu aþamada çivi uzunluðunu deðiþtirmeyiniz ve yeniden hizalama yapmayýnýz.
Femoral çiviyi priformis fossada açýlmýþ olan deliðe elle yavaþça ittiriniz. Tibia guide vidalarýna
slide hammer (Ref: 10611031001) baðlayýnýz. Bu çekiç vasýtasýyla çiviyi yerine çakýnýz. Çiviyi
çakarken aþýrý yüklenmeden kaçýnýnýz.
Proximal Locking
Proksimal Kilitleme
The aligned Tibia Guide-Short (Left-Right) (Ref:106060460020-10606460021) is mounted
to Tibia Guide Attachment and fixed. A Skin incision should be performed so that Drill
Sleeves Long (Ref:10606181007) can be slided through both holes in Guide-Short up to
tibia. After Drill Sleeves Long are inserted appropriate Drill Sleeves (Ref:10606181003-04)
(Ø3.5, Ø4.0) are inserted inside the Drill Sleeves Long(Ref:10606181007). Long Drill (Ø3.5,
Ø4.0) is put into the Drill Guide, and drilled through the medial and lateral cortex. Firstly
the first proximal hole should be drilled. Special attention has to be paid that the drill
passes directly through the proximal holes of tibia nail. Tibia Guide-Short Proximal Holes
should result in precise drilling.
Hizalanmýþ Tibia Guide Short (uygunluðuna göre sol ya da sað) (Ref:10606046002010606460021) Tbia Guide Attachment üzerine monte edilir ve sabitlenir. Cilt kesisi yapýlýr.
Böylece drill sleeve uzun (Ref:10606181007) femura kadar ayarlanabilir kayma aparatýndaki
deliklerin ikisine de kaydýrýlabilir. Drill Sleeve Ø8 Uzun, kaydýrýlabilir aparattaki deliklere
yerleþtirildikten sonra uygun çaptaki drill sleeve (Ref: 10606181001-03-04) (Ø2.1, Ø3.5, Ø4)
Drill Sleeve Ø8 Uzun içerisine yerleþtirilir. Long Drill (q4.0, q4.8) Drill Guide içine yerleþtirilir ve
lateral ve medial cortekse doðru delinir. Öncelikle ilk proksimal delik açýlýr. Drill’in direkt
olarak tibia çivisinin proksimal deliklerine geçmesi için dikkatli olunmalýdýr. Tbia Guide Short
proksimal deliklerin hassas bir þekilde delinmesine olanak saðlar.
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
7
T 2 006
TIBIA INTERLOCKING NAIL SYSTEM
Long Drill and Drill Guide is removed from the apparatus, Screw Length Gauge
(Ref:10608081001) is inserted in the Screw Guide and the length of screw is determined
by this measurement.
Long Drill ve Drill Guide aparattan sökülür, Vida Uzunluk Ölçücü (Ref:10608081001)
Vida Guide’a yerleþtirilir ve vida uzunluðu tespit edilir.
The screw is locked by inserting and screwing through the Screw Guide using T
Wrench (Ref:10604011401 or 10604011402). The operations are repeated for the other
proximal hole.
T-anahtarý (Ref:10604011401 or 10604011402) yardýmýyla vida, vida kýlavuzuna sokulur
ve vidalanarak kilitlenir. Bu operasyonlar diðer proksimal delik için de tekrarlanýr.
Locking of proximal holes for tibial nail is completed. Screw Guide and Tibia GuideShort can be dismounted.
Tibial çivinin proksimal deliklerinin kilitlenmesi tamamlandýktan sonra, vida guide ve
tibia guide short çýkarýlabilir.
Distal Locking
Distal Kilitleme
The aligned Tibia Guide-Long is mounted to Tibia Guide Attachment and fixed at
the nail length (Fig.1).
Hizalanmýþ olan tibia guide long çivi uzunluðunda olacak þekilde tibia guide
attachment’e monte edilir.
8
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
T2 00 6
TIBIA INTERLOCKING NAIL SYSTEM
A Skin incision should be performed so
that Screw Sleeves (Ref:10606181007) can be
slided through both holes in adjustable sliding
apparatus up to tibia. After Screw Sleeves
are inserted appropriate Drill Sleeves are
inserted inside the Drill Sleeves Long. Long Drill
(3.5, Ø4.0) is put into the Drill Guide (3.5, Ø4.0),
and drilled through the medial and lateral
cortex. Firstly the last distal hole should be
drilled. Special attention has to be paid that
the drill passes directly through the distal holes
of tibia nail, adjustable slotted apparatus
should result in precise drilling.
Cilt kesisi yapýlýr. Böylece vida sleeve’leri
(Ref:10606181007) tibiaya kadar ayarlanabilir
kayma aparatýndaki deliklerin ikisine de
kaydýrýlabilir. Vida sleeve’leri uygun Drill Sleeve
(Ø3.5, Ø4.0) içine yerleþtirildikten sonra drill
sleeve long içerisine yerleþtirilirler. Long Drill
(Ø4.0, Ø4.8) Drill Guide içine yerleþtirilir ve
lateral ve medial cortekse doðru delinir.
Öncelikle son distal delik açýlýr. Drill’in direkt
olarak tibia çivisinin distal deliklerine geçmesi
için dikkatli olunmalýdýr. Ayarlanabilir slotlu
aparat hassas bir þekilde delmeyi saðlar.
Long Drill and Drill Guide is removed from the apparatus, Screw Length Gauge is
inserted in the Screw Guide and the length of screw is determined by this measurement.
Long Drill ve Drill Guide aparattan sökülür, Vida Uzunluk Ölçücü Vida Guide’a
yerleþtirilir ve vida uzunluðu tespit edilir.
The screw is locked by inserting and screwing through the Screw Guide using T
Wrench. The operations are repeated for the other distal hole.
T-anahtarý (ref) yardýmýyla vida, vida kýlavuzuna sokulur ve vidalanarak kilitlenir. Bu
operasyonlar diðer distal delik için de tekrarlanýr.
Locking of distal holes for tibial nail is completed. All apparatus can be dismounted.
Böylece tibial çivinin distal deliklerinin kilitlenmesi tamamlanmýþ oldu. Tüm aparatlar
çýkarýlabilir.
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
9
T 2 006
TIBIA INTERLOCKING NAIL SYSTEM
End Cap Insertion
End Cap Yerleþtirilmesi
By mounting the Locking End Cap
(Ref:10802291002) at the top of Tibia Nail. The
procedure is finalized and ingrowth of bone
is made impossible.
Locking End Cap’ýn tibia çivisinin
tepesine geçirilmesiyle proses tamamlanmýþ
ve kemiðin içe doðru büyümesi engellenmiþ
olur.
10
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
T20 0 6
TIBIA INTERLOCKING NAIL SYSTEM
Instruments & Trays/El Aletleri & Tavalar
tray 1
tray 2
tray 3
tray 4
tava 2
tava 1
tava 3
tava 4
10604001013
T Handle for Flexible Reamer
10604011401
T Wrench for Canullated Screw / 4
T Kol Fleksibl Oyucu
Kanüllü Vida T Anahtarý / 4
T Wrench for Canullated Screw / 5
10604011402
Kanüllü Vida T Anahtarý / 5
10604051003
Double Open Wrench
10604071105
T Wrench for Femur-Tibia Adjusted Guide
10606011340
Trocar AWL
10606061003
Reamer Guide Rod Holder
Ýki Aðýzlý Anahtar
Ayarlý Guide T Anahtar
Trokar AWL
Tutucu
Cortical Awl
10606111002
Kuntscher Bizi
10606170305
Tapered Reamer Canullated
10606181001
10606181003
10606181004
Drill Sleeve
Ø2.1
Ø3.5
Ø4.0
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
Kanüllü Oyucu
11
T 2006
TIBIA INTERLOCKING NAIL SYSTEM
10606181007
Drill Sleeve Ø8.0 Long
10606190011
Tube For Intramedular Nail
10606191002
Guide Rod for Intramedular Nail-Straight / Ø2.5 x 750
10606191003
Guide Rod for Intramedular Nail-Straight / Ø3.0 x 750
10606191022
Guide Rod for Intramedular Nail-Spherical Tip / Ø2.5 x 750
10606191023
Drill Sleeve Ø8.0 Uzun
Teflon tüp
Tel Guide-Düz / Ø2.5 x 750
Tel Guide-Düz / Ø3.0 x 750
Tel Guide-Küre Uçlu / Ø2.5 x 750
Guide Rod for Intramedular Nail-Spherical Tip / Ø3.0 x 750
Tel Guide-Küre Uçlu / Ø3.0 x 750
Tibia Guide Attachment
10606460010
Tibia Guide Parçasý
10606460015
Tibia Guide Screw
Tibia Guide Çektirme Civatasý
10606460020
10606460021
Tibia Guide Short Left-Tibia Guide Sol
Tibia Guide Short Right-Tibia Guide Sað
10606460025
Tibia Guide Long
10606460028
Fixation Guide for Tibia Guide
10606460035
Positioning Atatchment
10606460038
Positioning Guide
10608081001
Screw Length Gauge
10608081002
Ruler
10608081003
Skin Protector
Tibia Guide Uzun
Tibia Guide için Tespit klavuzu
Pozisyon Aparatý
Pozisyon Gaydý
Vida Uzunluk Ölçer
Cetvel
Cilt Koruyucu
Flexible Reamer
Fleksibl Oyucu
10610091005
10610091007
10610091009
10610091011
10610091013
10610091015
10610091017
Ø8
Ø9
Ø10
Ø11
Ø12
Ø13
Ø14
12
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
T 2006
TIBIA INTERLOCKING NAIL SYSTEM
10610091100
Flexible Reamer Attachment
10611031001
Slide Hammer
10611031002
Tibial Extractor Bolt
10611031003
Supine Driver
Long Drill
Fleksibl Reamer Tutucu Adaptör
Çakýcý/Çýkarý
Çýkarýcý Ucu
10809021002
10809021005
Uzun Drill
10809031211
Canullated Drill Ø4.0
Ø3.5
Ø4.0
Kanüllü Drill
13
SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK
IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ
Revision 03 / Printed in TURKEY - 09/11 - TIPSAN Design
The products being manufactured by TIPSAN A.S. has been certified from SZUTEST (Strojírensk•
Zkušební Ústav) for EC certificate (CE 1015) according to Annex II. 3 and II.4 of Council Directive
93/42/EEC concerning medical devices
Kemalpasa Cd. 404/1 Sk. No: 3 Pinarbasi - IZMIR - TURKEY
Tel: +90 232 479 56 54 Fax: +90 232 479 58 27
[email protected] www.tipsan.com.tr

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